A blog about what is new (and old) in the world of active implantable medical devices

Category Archives: Treated Conditions

Implantable Devices to treat specific conditions

Biotronik presents 24-month interim data from the BENEFIT-03 clinical study at NANS

Posted on by Posted in Biotronik, Pain, Spinal Cord Stimulation
Biotronik Prospera IPG

Image Credit: Biotronik

Biotronik received FDA approval for its Prospera™ Spinal Cord Stimulation System on March 31, 2023. The system is intended to treat chronic, intractable pain in the trunk or limbs.  The Prospera SCS System includes a rechargeable IPG, SCS leads, a clinician programmer, a patient programmer, and an external trial pulse generator.

This weekend at NANS 2025 Biotronik presented  24-month intermediate data from its BENEFIT-03 prospective, multicenter clinical study in Australia.  Continue reading→

Neuronoff’s Injectrode Transcutaneously-Powered Nerve Stimulation

Posted on by Posted in Neural Stimulation, Neuronoff, Pain, PNS, Spinal Cord Stimulation
Neuronoff Injectrode

Image Credit: Neuronoff

Some time ago, I posted about Bioness’ “StimRouter”, which is an externally-powered implantable peripheral nerve stimulator designed to reduce chronic pain. Unlike most externally-powered neurostimulators this device is not powered by RF received from the external transmitter. Instead, the external pulse transmitter is more like a TENS unit with gelled electrodes applied to the skin. The implant has no electronic components. It is just a lead that has a coil electrode that intercepts part of the current between the TENS electrodes, and routes the captured current to small electrodes in contact with the target nerve at the distal end of the lead.

A similar approach is now being trialed under an IDE by Cleveland-based Neuronoff, Inc.  Their “Injectrode” approach consists of an implanted lead that is injected via an 18 ga needle injection.  The lead is activated transcutaneously with an external stimulator. Continue reading→

History: Mennen Medical and the First Israeli Pacemakers 1976-1980

Posted on by Posted in Bradycardia, Cardiac Pacing, Greatbatch Medical (Power), History, Mennen Medical (1976-1980), Museum, Omikron Scientific (1979-1985)
Mennen Medical’s Model 801 pacemaker. From: https://www.makash.org.il/sy/jerusa_book.pdf

Mennen Medical’s Model 801 pacemaker. From: Dr. Shmuel Yerushalmi’s memoir at www.makash.org.il/sy/jerusa_book.pdf

I spent the year-end holidays in Israel and had the pleasure of speaking with some of Mennen Medical’s and Omikron Scientific’s first employees regarding the efforts that these companies made in the late 1970s and early 1980s towards the development and manufacture of pacemakers in Israel.

Benny Kiron, who joined Mennen Medical in 1976 as a product designer, referred me to Dr. Shmuel Yerushalmi’s memoir at www.makash.org.il/sy/jerusa_book.pdf, from which I was finally able to understand the origin of Mennen Medical’s pacemaker project, as well as its relationship with Omikron Scientific.

Dr. Shmuel Yerushalmi was born in Brasil and emigrated to Israel in 1956. In 1976, while still pursuing his doctorate at the prestigious Weizmann Institute, he started working at the Israeli subsidiary of Mennen-Greatbatch of Clarence, NY.

The Mennen-Greatbatch partnership was dissolved when Wilson Greatbatch decided to concentrate on lithium battery development, and the Israeli company became a subsidiary of Mennen Medical, where an implantable pacemaker project was started.

RF-powered pacemaker developed by the Weizmann Institute and meant for production by Elta. From: https://www.makash.org.il/sy/jerusa_book.pdf

RF-powered pacemaker developed by the Weizmann Institute and meant for production by Elta. From: Dr. Shmuel Yerushalmi’s memoir at www.makash.org.il/sy/jerusa_book.pdf

Shmuel Yerushalmi had worked on the development of an RF-powered pacemaker while still a technician at the Weizmann institute, so his experience was tapped at Mennen Medical to lead the development of a VVI pacemaker powered by a Greatbatch lithium battery. The project was supported by Israel’s Chief Scientist Office and the BIRD (Israel-US Binational Industrial Research and Development) Foundation .

PCBA of Mennen Medical’s Model 801 pacemaker. Device was kindly gifted to me by Koby Kamin. ©2025 David Prutchi.

PCBA of Mennen Medical’s Model 801 pacemaker. Device was kindly gifted to me by Koby Kamin. ©2025 David Prutchi.

Continue reading→

Glucotrack starts study enrollment of implantable CGBM

Posted on by Posted in Diabetes, Glucose Monitoring, Glucotrack
Glucotrack's implantable continuous glucose monitor

Image Credit: Glucotrack

Glucotrack announced that it has started enrolling a feasibility study for its implantable continuous blood glucose monitoring (CBGM) device.  The study will include participants with both type 1 and type 2 diabetes, with data from the study expected to be available within 6-8 weeks.

According to the company, “unlike traditional continuous glucose monitors that measure glucose levels in interstitial fluid, Glucotrack’s CBGM measures glucose directly from blood, aiming to provide real-time readings without the lag time typically associated with interstitial glucose measurements. The CBGM is a long-term implantable device with no on-body external component, designed for three years of continuous, accurate blood glucose monitoring, offering a more convenient and less intrusive glucose monitoring solution.”

Continue reading→

Paxos Medical developing neurostimulator for on-demand bladder voiding

Posted on by Posted in BladderVoiding, Paxos Medical
Paxos Medical is developing an implantable neuromodulation system that allows on demand bladder voiding without the use of 4-6 daily self-catheterizations for underactive bladder patients.

Image Credit: Paxos Medical, captured from Paxos Medical’s Lightning Pitch

Paxos Medical was founded in 2022 by Matthew Fraser, PhD and Jeff Erb in Marple Trail, Minnesota.  The company is developing an implantable neuromodulation system that allows on-demand bladder voiding, and is intended to replace the need for 4-6 daily self-catheterizations for underactive bladder patients.

Detailed information is still scarce, but the PCT publication of their patent application indicates that the idea is to stimulate the nerves of the proximal urethra to initiate and sustain urination.  Paxos has mentioned that 60 seconds of stimulation to pro-voiding nerve bundles can drive a void to completion.

 

 

Interesting Paper on Dorsal Root Ganglion Stimulation to Increase Diuresis

Posted on by Posted in Diuresis, Heart Failure (CHF), Medtronic
From Pawel et al., "Electrical Diuretics: Dorsal Root Ganglion Stimulation to Increase Diuresis,"Neuromodulation: Technology at the Neural Interface, Volume 27, Issue 7, 2024, Pages 1208-1217

From Pawel et al., “Electrical Diuretics: Dorsal Root Ganglion Stimulation to Increase Diuresis,”
Neuromodulation: Technology at the Neural Interface, Volume 27, Issue 7, 2024, Pages 1208-1217

Scientists from Medtronic’s Bakken Research Center in The Netherlands, along with collaborators from Poland just published a paper on increasing diuresis through Dorsal Root Ganglion (DRG) stimulation as a potential therapy for heart failure.

The paper “Electrical Diuretics: Dorsal Root Ganglion Stimulation to Increase Diuresis” was published in Neuromodulation: Technology at the Neural Interface (Volume 27, Issue 7, 2024, Pages 1208-1217).  A summary abstract is available from Elsevier.  It explains:

“Stimulation of diuresis is an essential component of heart failure treatment to reduce fluid overload. Over time, increasing doses of loop diuretics are required to achieve adequate urine output, and approximately 30% to 45% of patients develop diuretic resistance. We investigated the feasibility of affecting renal afferent sensory nerves by dorsal root ganglion neurostimulation as an alternative to medication to increase diuresis.”

The study was conducted in 7 pigs and showed that electrical stimulation (bDRG) at T11 and/or T12 caused an average diuresis increased 20% to 205% compared with no stimulation.   The authors report that side effects such as motor stimulation were mitigated by decreasing current or terminated spontaneously without intervention, and that there was no negative effect on acute kidney function because blood electrolyte concentrations remained stable.

Affluent Medical’s Artus Artificial Sphincter for Urinary Incontinence

Posted on by Posted in Affluent Medical, Artificial Sphincter, Incontinence, MPS Micro Precision Systems, Myopowers
Affluent Medical's Artus artificial sphincter for urinary incontinence

Image credit: Affluent Medical

Walking down MD&M Minneapolis’ aisles, I saw an implantable device that I hadn’t seen before. It is an artificial mechanical sphincter being developed by Affluent Medical based in Aix-en-Provence, France.  The device is aimed at treating stress urinary incontinence, which is a disabling condition that results in uncontrolled urinary leakage during effort such as coughing or sport.

Continue reading→

ShiraTronics raises $66M for pivotal trial treating migraine

Posted on by Posted in Cluster Headaches, Migraine, Occipital Nerve Stimulation, ShiraTronics

 

ShiraTronics Implantable device for the treatment of migraine

Image Credit: ShiraTronics

Broolin Park (MN)-based ShiraTronics  developed a system that is intended to provide electrical stimulation to nerves associated with migraine pain. The therapy includes a temporary Trial System and a permanent Implant System. The Trial System components include percutaneous leads temporarily placed in the supraorbital and occipital regions. The Implant System components include rechargeable IPGs with integrated leads. The IPGs are implanted in subcutaneous pockets posteriorly on the head with leads tunneled to the supraorbital and occipital regions. Both systems are controlled by a programmer with a therapy application.

This summer ShiraTronics presented 12-week results on 10 patients enrolled its pilot clinical trial in Australia of its implantable system intended for the prophylactic treatment of refractory chronic migraine.

ShiraTronics announced yesterday the closing of a $66 million Series B financing.  According to the press release:

“This latest round of funding will support ShiraTronics’ recently launched U.S. Food and Drug Administration (FDA)-approved pivotal trial, the RELIEV-CM2 Clinical Study, a multi-center, blinded, randomized, sham-controlled clinical trial. The trial is designed to evaluate the safety and effectiveness of the company’s Migraine Therapy System in patients who have failed current medical therapies and have treatment-resistant chronic migraine. The financing also will support the company as it seeks premarket approval from the FDA and fund the initial commercial launch of its innovative therapy for chronic migraine patients.”

Axonics Prevails in Patent Infringement Lawsuit with Medtronic

Posted on by Posted in AIMD Business, Axonics, Bowel Discfunction, Incontinence, Medtronic, Sacral Root Stimulation, Wireless Power Transmission
Axonix rechargeable stimulator

Image Credit: Axonix

Axonix announced that a jury in the U.S. District Court for the Central District of California returned a unanimous verdict in the patent infringement lawsuit brought by Medtronic against Axonics in Axonix favor.

The jury ruled unanimously for Axonics, on claims related to three separate patents.  One relates to transcutaneous recharging, and the other two two  to the implantation of electrodes for stimulating the sacral nerve to help support urinary and bowel control.

The case has been one of several intellectual property disputes between Medtronic and Axonics, which is expected to become a Boston Scientific subsidiary in a $3.7 billion deal.

 

Comphya’s CaverSTIM System to treat Erectile Disfunction

Posted on by Posted in Cavernous Nerve Stimulation, Cirtec, Comphya, Erectile Disorder
CaverSTIM IPG for ED by Comphya

Image Credit: Comphya

Comphya is a company based in Lausanne, Switzerland developing a system for the treatment of erectile disorder due to spinal cord injury or prostatectomy.

The CaverSTIM System is based on the Algovita Platform which was acquired by Cirtec when Nuvectra declared bankruptcy.

The IPG provides self-controlled stimulation (via a wireless remote control) to the cavernous nerve to restore natural erectile function. According to Comphya, their innovation has a key element which can overcome a major barrier for the therapy, the complex anatomy of the neural path for erection, and it can guarantee the identification of the site for stimulation within the pelvic cavity.   Comphya has tested this in an acute clinical trial (J Sex Med. 2018 Nov;15(11):1558-1569).

Their first implant took place in August 2023 at the Royal Melbourne Hospital.  In October of 2023, the device was first implanted in a spinal cord injury patient at Hospital Mario Covas in Brazil. More recently, in August 2024 Comphya announced that it had received approval from the Brazilian National Research Ethics Committees (CEP and CONEP) and the federal regulatory authority ANVISA to initiate a pilot clinical trial in patients undergoing prostatectomy.

CaverSTIM system by Comphya

Image Credit: Comphya

FDA approves Senseonics’ Eversense one-year implantable CGM

Posted on by Posted in Diabetes, Glucose Monitoring, Senseonics

Senseonics implantable glucose sensor www.implantable-device.com David Prutchi PhD

Senseonics announced that it had received FDA’s approval for its next-generation Eversense® 365 Continuous Glucose Monitoring (CGM) system for people with Type 1 and Type 2 diabetes aged 18 years and older. Eversense 365 is the world’s first One Year CGM system.

According to the announcement, “Eversense 365 has been cleared as an integrated CGM (iCGM) system, indicating that it can integrate with compatible medical devices, including insulin pumps as part of an automated insulin delivery (AID) system.”

 

Neuralink receives FDA’s Breakthrough Device designation for its Blindsight Device

Posted on by Posted in Blindness, Brain Stimulation, Neuralink
Neuralink implant

Image credit: Neuralink

Yesterday Neuralink announced that its Blindsight Device had been granted “Breakthrough Device” designation by the FDA.  According to Elan Musk, the device “will enable even those who have lost both eyes and their optic nerve to see.”

Details about the Blindsight Device or commencement of a clinical trial are scarce at this time.

Fire1’s Inferior Vena Caval Size Monitor

Posted on by Posted in FIRE1, Heart Failure (CHF), IVC Monitoring
Fire 1 Inferior Vena Caval Size Monitoring

Image Credit: Fire 1

FIRE1 is an Ireland-based company developing an implantable Inferior Vena Cava (IVC) size sensor for heart failure monitoring.   The FIRE1 System is a device designed to directly measure a patient’s volume status by measuring the IVC, which is the largest vein in the body where most fluid is stored.

The FIRE1 sensor is implanted at the abdominal level and works by measuring the size of the IVC to give a marker of the amount of fluid in the body. High levels can increase the risk of breathing difficulties and a build-up of fluid in the lungs which lead to an emergency hospital admission. The patient wears a belt reader around the abdomen for around a minute a day to take a reading from the sensor and the data is sent to the patient’s clinical team at the hospital. The system is designed to alert whenever the patient’s condition deteriorates.

In March 2024, FIRE1 announced that it has completed patient enrollment in the U.S. Early Feasibility Study (FUTURE-HF2) of its system. Results presented at CRF’s THT showed that all enrolled patients (n=8) met their safety and effectiveness endpoints.

Update on Device Based Therapies in Heart Failure published by HFSA

Posted on by Posted in Abbott, Baroreceptor Stimulation, Berlin Heals, Biotronik, Boston Scientific, Cardiac Contractility Modulation, Cardiac Neuromodulation, Cardiac Pacing, Cardiac Stimulation (other), CardioMEMS, Cardioversion/Defibrillation, Circulatory Support, CVRx, Edwards, Endotronix, Heart Failure (CHF), Impulse Dynamics, Medtronic, Microcurrent, Respicardia, Ventricular Assist Device, Viscardia
From: HFSA Scientific Statement: Update on Device Based Therapies in Heart Failure, ESTEP, JERRY D. et al., Journal of Cardiac Failure, 2024

From: HFSA Scientific Statement: Update on Device Based Therapies in Heart Failure, ESTEP, JERRY D. et al., Journal of Cardiac Failure, 2024

The Heart Failure Society of America (HFSA) published today a new Scientific Statement titled “Update on Device Based Therapies in Heart Failure.”  The statement was published online in the Journal of Cardiac Failure (JCF).

This statement discusses how novel device-based therapies, including CCM, BAT, and remote monitoring may bridge current gaps in HF treatment and outcomes.  The statement also proposes a clinical pathway to implement FDA approved device-based therapies that align with current HF management workflow.

 

 

Abbott starts clinical trial of DBS to treat depression

Posted on by Posted in Abbott, Brain Stimulation, Depression
Abbott St Jude Medical Infinity DBS IPG

Image Credit: Abbott

Back in 2022, the FDA granted Abbott Breakthrough Device designation for deep brain stimulation (DBS) for treatment-resistant depression (TRD), a form of major depressive disorder.  Now Abbott announced it has initiated a pivotal clinical trial, called the TRANSCEND study, to evaluate the use of the company’s DBS system to manage TRD.

Previous open-label studies exploring the use of DBS for TRD have shown at least a 50% sustained improvement in symptoms of depression for three out of four people over a period of two to eight years.

Continue reading→